510(k) K973962 ยท DSP System, Balloon, Intra-Aortic And Control
BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS
| Applicant | C.R. Bard, Inc., Haverhill MA, US |
| Decision | Substantially Equivalent, Feb 19, 1998 |
| Received | Oct 16, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973962
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.